くすりのしおり

Internal
Revised: 6/2019

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Didronel Tablets 200
 Active ingredient:
Etidronate disodium
 Dosage form:
white tablet, diameter: approx. 9mm, thickness: approx. 3.5mm
 Print on wrapping:
(face)ダイドロネル 200, ダイドロネル, 200, #202
(back) Didronel 200, ダイドロネル, 200

Effects of this medicine

This medicine increases bone mass in order to treat disease which reduces calcium in bone (bone mass) and makes bone spongy. It also suppresses incidence of metastatic ossification (calcium deposit in the part which is not bone), which is often seen after spinal (backbone) damage or hip surgery, as well as to control symptoms and progression of Paget's disease of bone which causes bone enlargement and bone malformation.
It is usually used to suppress metastatic ossification after spinal damage or hip arthroplasty and to treat Paget's disease of bone.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reaction (itch, rash etc.) to any medicines.
    If you are a patient with renal disorder or osteomalacia.
    If you are a child.
  • If you are pregnant, possibly pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • General dosage regimen:
  • For the treatment of osteoporosis: For adults, take 1 tablet (200mg of the active ingredient) once a day, between meals, for 2 weeks. After that, discontinue the medicine for 10 to 12 weeks. Repeat this cycle. If symptoms are severe, the dose may be increased up to 2 tablets (400mg) a day. The dose may be adjusted according to your age and symptoms, and it should not exceed 2 tablets (400mg) a day. Strictly follow the instructions.
  • For the treatment of metastatic ossification which is often seen after spinal (backbone) damage or hip surgery: For adults, take 4 to 5 tablets (800 to 1,000mg of the active ingredient) once a day, between meals. The dose may be adjusted according to your age and symptoms. Strictly follow the instructions.
  • For the treatment of Paget's disease of bone: For adults, take 1 tablet (200mg of the active ingredient) once a day, between meals. The dose may be adjusted according to your age and symptoms, and it should not exceed 5 tablets (1,000mg) a day. Strictly follow the instructions.
  • Do not eat anything for each 2 hours before and after taking the medicine, not to disturb absorption of the medicine.
    In any case, strictly follow the instructions of your doctor or pharmacist.
  • The medicine is to be taken once a day. So, if you realize that you missed a dose on that day, take the missed dose according to the instructions. However, even though you missed a dose, you should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • If you need to be treated by a dentist/oral surgery specialist while you are receiving the medicine's treatment (including both duration of drug exposure and drug holidays), tell him/her the name of the medicine beforehand.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include stomach discomfort, diarrhea/loose stool, nausea, stomachache, vomiting, loss of appetite, rash, itch, hives, and angioedema. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • pain/oppressive pain in the pit of the stomach, heartburn, burp  [peptic ulcer]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes  [liver dysfunction, jaundice]
  • general malaise, headache, sore throat  [pancytopenia, agranulocytosis]
  • sore/swollen gum, pain in the jaw, tooth looseness, toothache, drainage from the gum  [necrosis of the jaw bone, osteomyelitis of the jaw]
  • ear pain, itch of the ear, ear discharge [osteonecrosis of external auditory canal]
  • pain of the thigh or an inguinal region  [atypical subtrochabteric and diaphyseal femoral fractures]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.